8:15 am Morning Refreshments & Check In
9:00 am Opening Remarks
9:05 am Chair’s Opening Remarks
Driving MASH Innovation from Lessons Learned in Clinical Trials & Approved Therapies to Accelerate Candidates Through Phase 2 & Beyond to MASH Patients
9:15 am Spotlighting Madrigal’s MASH Breakthrough to Explore the Treatment Success & Benchmark for the Next Therapeutic Era
Synopsis
- Informing on Madrigal’s breakthrough drug to further understand how it succeeded in revolutionizing the MASH treatment landscape, leading to a new standard of care for patients
- Reviewing compelling evidence from robust clinical data and real-world evidence to demonstrate the treatment’s significant effectiveness to inform on treatment decisions and improve patient outcomes
- Examining ongoing research and future directions to accelerate the development of more effective MASH therapies for a cure and better long-term management of the disease
9:45 am Evaluating the MASH Landscape to Understand How Interdisciplinary Approaches Can Drive Clinical Advancements to Treat the Complex Patient Population
Synopsis
- Highlighting interdisciplinary collaborative strategies to enhance MASH understanding to create more personalized treatment strategies
- Reviewing innovative methodologies to utilize new research approaches and improve clinical trial design to accelerate the development of MASH therapies
- Emphasizing the need for comprehensive care to combine the expertise from vary
10:15 am Making MASH a Strategic & Commercial Priority to Advance Next-Gen Therapies for More Effective Drug Development
Synopsis
- Addressing the MASH opportunity to emphasize the crucial role of synergistic novel scientific approaches and strategic collaborative partnerships to drive the development of the next generation of effective therapies
- Prioritizing a review for next-generation therapies to understand the most promising emerging therapeutic avenues, including cell-based therapies and combination approaches, to strategically advance the future of MASH treatment, improve patient outcomes, and enhance commercial viability
- Exploring novel strategies and regulatory advancements to advance innovation and market access to accelerate processes, optimize resource allocation, secure a broad spectrum of MASH treatment options for patients, and facilitate market penetration
10:45 am Speed Networking Session
Synopsis
Put a face to a name – this session is the perfect opportunity to get face-to-face time with key opinion leaders, leading companies, and innovative researchers in MASH drug development. Establish meaningful connections and gain individual insight beyond the papers and press releases into the pioneering research and therapeutic development.
11:30 am Morning Break & Networking
Revolutionizing MASH Diagnosis Using Non-Invasive Biomarkers to Enhance Precision for Earlier Detection to Improve Patient Outcomes
11:45 am One Drop, One Answer: Galactose Single Point for Tracking Liver Health in MASH
Synopsis
- A simple, rapid, and quantitative method for assessing liver function
- A POC quantitative non-invasive test for MASH: Insights from animal and clinical trials
- Exploring a safe, simple, and highly sensitive quantitative liver function test
12:15 pm Redefining Clinical Trial Endpoints in MASH with Quantitative Imaging and Digital Pathology
Synopsis
- Measure treatment response in MASH with confidence using quantitative multi-organ and body composition imaging
- Combine digital pathology with quantitative imaging to streamline outcome measures and optimize trials for accelerated approval pathways
1:15 pm Utilizing AI-Based Digital Pathology to Evaluate Denifanstat’s Anti-Fibrotic Effect in MASH Patients with Advanced Fibrosis
Synopsis
- Reviewing denifanstat’s MOA and its robust anti-fibrotic effect in MASH patients with F3 fibrosis
- Applying digital pathology to assess the anti-fibrotic effect of denifanstat in MASH patients with advanced fibrosis
- Utilizing zonal analysis to explore denifanstat’s potential to offer long-term clinical benefit
1:45 pm Lunch
Evaluating Patient Populations in MASH Clinical Trials to Tackle Fibrosis Severity & Incorporate Global Perspectives for More Precise & Impactful Trial
2:45 pm Leveraging Biomarkers for Efficient MASH Patient Stratification to Reduced Screen-Failures in Clinical Trials
Synopsis
- Reviewing simple biomarkers to pre-screen patients for liver directed therapy and clinical trials
- Using advanced biomarkers to screen-patients for clinical trials and reduce screen-fail rate
3:15 pm From Steatosis to Fibrosis & Beyond –Non-Invasive Imaging in MASLD/MASH
Synopsis
- Understanding the complexity of MASLD/MASH and its downstream consequences
- New advances in clinical non-invasive imaging of fibrosis and cirrhosis
- How insights from multiple biomarkers can shape and accelerate decision-making in drug development
3:45 pm Afternoon Networking Break & Poster Session
Synopsis
Connect with peers in a relaxed atmosphere and continue to forge new and existing relationships while exploring the latest in MASH research and advancements. To submit a poster, please contact info@hansonwade.com
4:15 pm Identifying MASH Patients with Active Fibrogenesis: Biomarker Strategies for Early Proof-of-Concept Antifibrotic Trials
Synopsis
- Differentiating fibrosis stage from fibrogenic activity in the context of antifibrotic therapy development
- Leveraging real-world screening data to characterize patients with active, ongoing fibrogenesis
- Exploring pre-identification tools (including but not limited to AST, FAST score and LiverPRO) and treatment monitoring strategies
4:45 pm HepQuant DuO™ Defines Risk for Clinical Outcome and Quantifies Changes in Risk
Synopsis
- Fully characterize the spectrum of liver health within study populations by measuring liver function and physiology
- Estimate clinical outcome from DSI and ∆DSI after a treatment intervention, using RISK ACE Score
- With functional characterization and identification of the high risk Child Pugh A patient, a smaller sample size and shorter trial duration can more efficiently achieve the endpoint of clinical outcomes in a cirrhotic trial
5:15 pm Session Reserved for Summit Clinical Research
5:45 pm Roundtable Discussion: Optimizing Patient Selection to Improve MASH Trial Outcomes for Global Treatment Success
Synopsis
- Emphasizing the necessity of incorporating non-invasive tests (NITs) to complement or potentially replace liver biopsies in MASH clinical trials, especially in global settings, to improve patient comfort, reduce screening failures, and enhance the feasibility of large-scale studies
- Highlighting the importance of addressing the heterogeneity of MASH across different ethnicities and geographical regions by employing tailored patient selection strategies that account for genetic variations, environmental factors, and regional disparities in disease presentation
- Discussing the need for collaborative efforts among researchers, clinicians, regulatory agencies, and industry stakeholders to establish standardized patient selection criteria and promote the inclusion of diverse populations in MASH clinical trials, ultimately leading to more generalizable and effective treatments